Understanding the Health Claims Paradigm

Its been 20 years since the passage of the Nutrition Labeling and Education Act of 1990 (NLEA), which changed the landscape to allow manufacturers to provide additional health information" to consumers via health claims on foods. Writing for INSIDERs sister publication,  Food Product Design, Kimberly Decker explored the current state of the health claims landscape, providing an overview of the types of claims and a few best practices.

Nutrition trends and regulatory oversight both swing like a pendulum, with a heavier hand from the government during periods with certain problems, or a push from manufacturers that have found something that addresses certain consumer needs. Decker noted the regulatory process tends to evolved based as much on politics as scientific merit.

At this point, however, there are several different types of health claims a company can explore. The most basic are nutrient-content claims, which help characterize the level of a specified nutrient in a food; these include your good" and excellent" source claims, as well as low" or high" claims as related to the recommended daily intake. Next up are the FDA authorized-health claims, which characterize the relationship of a substance in a food to a certain health condition. FDA has approved 13 such claims, judging them to meet the significant scientific agreement" baseline. Companies can also made health claims based on authoritative statements from scientific bodies such as the National Institutes of Health (NIH) or National Academy of Sciences (NAS). The company notifies FDA of its intent to use the claim; if the agency does not respond to the notification within 120 days, the company can move forward.

The situation gets murkier in the areas of qualified health claims and structure/function claims. In the case of qualified health claimsan area carved out after the Pearson v Shalala decisioncompanies can petition FDA with emerging evidence of a relationship between a nutrient or food and health condition, which the agency reviews and can allow with a letter of enforcement discretion. Decker noted FDA makes it clear how strong the qualification must be, and companies must follow the exact wording used in that letter from the agency.

The final area Decker details is structure/function claims, originally addressed in the Dietary Supplement Health & Education Act (DSHEA) of 1994. At this point, s/f claims can discuss either the ability of a supplement or a food nutrients ability to maintain a normal body structure or function. However, there are pros and cons to determining whether the product itself is a food or supplement when looking to use such claims in marketing. For example, supplement makers must notify FDA of their claims within 30 days of marketing the product, and the product must carry a certain disclaimer regarding FDA not evaluating the claim; structure/function claims related to nutrients in foods do not require the disclaimer or notification. On the flip side, supplements have a slightly greater degree of flexibility regarding the ingredients included in the product for notification, while food manufacturers must notify FDA before using a novel ingredient or have established GRAS (generally recognized as safe) status for that compound.